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2 clusters · 6 sources · 3 days · First seen · Last updated

FDA approval of Weltruza for schizophrenia

Overview

The U.S. Food and Drug Administration (FDA) has approved Weltruza, a once-monthly subcutaneous olanzapine injection for the treatment of schizophrenia in adults. Developed by Teva Pharmaceutical Industries in partnership with Medincell, the medication utilizes Medincell’s long-acting injectable polymer technology.

Unlike previous intramuscular formulations such as Zyprexa Relprevv, Weltruza is designed to eliminate the need for loading doses, oral supplementation, or post-injection observation at a certified facility. This distinction is significant as it avoids the requirement for patients to be monitored for potential post-injection delirium/sedation syndrome.

The treatment will be available in three strengths: 318 mg, 425 mg, and 531 mg, which correspond to daily oral doses of 10 mg, 15 mg, and 20 mg. Clinical trials indicated improved symptom scores and personal/social functioning compared to a placebo. Reported common adverse events include headache, sleepiness, increased weight, constipation, and injection site reactions.

Entities

Medincell · FDA · WELTRUZA · Teva Pharmaceuticals · United States

Timeline

  1. [HEALTH] 3 sources
    FDA approves Weltruza monthly subcutaneous olanzapine injection

    The FDA has approved Teva Pharmaceuticals' Weltruza, a once-monthly subcutaneous olanzapine injection for adults with schizophrenia that requires no post-injection monitoring.

  2. [HEALTH] 3 sources
    FDA approves WELTRUZA for schizophrenia treatment

    The FDA has approved WELTRUZA, a once-monthly subcutaneous olanzapine injection for adults with schizophrenia, developed by Teva Pharmaceutical Industries and Medincell.

Sources

medicaldaily.com · mugglehead.com · pharmabiz.net · pharmacytimes.com · psychiatrictimes.com · webdisclosure.com